Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 57961 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. On October 5, 

2023, the Committee will meet in open 

session to discuss the Strain Selection 

for the Influenza Virus Vaccines for the 

2024 Southern Hemisphere Influenza 

Season. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before September 27, 

2023, will be provided to the 

Committee. Comments received on or 

after September 28, 2023, and by 

October 4, 2023, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 11:20 

a.m. and 12:20 p.m. Eastern Time. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, along with their names, email 

addresses, and direct contact phone 

numbers of proposed participants, on or 

before 12 p.m. Eastern Time on 

September 20, 2023. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by 6 p.m. Eastern Time, 

September 22, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Sussan Paydar 

or Valerie Vashio (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18243 Filed 8–23–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3498] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Endocrinologic and 

Metabolic Drugs Advisory Committee 

(the Committee). The general function of 

the committee is to provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held 

virtually on September 21, 2023, from 9 

a.m. to 5:30 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/

AboutAdvisoryCommittees/ucm408555.

htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–3498. 

Please note that late, untimely filed 

comments will not be considered. The 

docket will close on September 20, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 20, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

September 15, 2023, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 


lotter on DSK11XQN23PROD with NOTICES1
57962 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–3498 for ‘‘Endocrinologic and 

Metabolic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–2855, email: EMDAC@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last-minute modifications that 

impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check FDA’s website at 

https://www.fda.gov/Advisory

Committees/default.htm and scroll 

down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. The Committee 

will discuss the safety and efficacy of 

ITCA 650 (exenatide in DUROS device), 

a drug-device combination product that 

is the subject of a new drug application 

(NDA) submitted by Intarcia 

Therapeutics, Inc. (Intarcia) (NDA 

209053), for the proposed indication, as 

an adjunct to diet and exercise, to 

improve glycemic control in adults with 

type 2 diabetes mellitus. CDER is 

holding this meeting pursuant to a 

March 24, 2023, letter from the Chief 

Scientist of FDA, Dr. Namandje ́ N. 

Bumpus, wherein she granted Intarcia’s 

request under 21 CFR 12.32(b)(3)(ii) for 

a public hearing before an advisory 

committee in lieu of a formal 

evidentiary hearing. Intarcia requested a 

public hearing before an advisory 

committee on CDER’s proposal to refuse 

approval of Intarcia’s NDA for ITCA 650 

(see Docket No. FDA–2021–N–0874). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before September 15, 

2023, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:30 p.m. and 2:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

September 13, 2023. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 14, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 57963 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact LaToya Bonner 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18250 Filed 8–23–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of a hybrid meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Service is hereby giving notice that the 

Presidential Advisory Council on HIV/ 

AIDS (PACHA or the Council) will 

convene the 78th full council meeting 

on Wednesday, September 20, 2023. 

The meeting will convene in Charleston, 

West Virginia and it will also utilize 

virtual technologies. The meeting will 

be open to the public. Due to limited 

space, pre-registration is encouraged for 

members of the public who wish to 

attend the meeting in-person. Please 

email your name to PACHA@hhs.gov by 

close of business Wednesday, 

September 13, 2023 to pre-reigster. 

There will be a public comment session 

during the meeting; pre-registration is 

required to provide public comment. To 

pre-register to provide public comment, 

please send an email to PACHA@

hhs.gov and include your name, 

organization, and title by close of 

business Wednesday, September 13, 

2023. If you decide you would like to 

provide public comment but do not preregister, you may submit your written 

statement by emailing PACHA@hhs.gov 

by close of business September 27, 

2023. The meeting agenda will be 

posted on the PACHA page on HIV.gov 

at https://www.hiv.gov/federalresponse/pacha/about-pacha prior to 

the meeting. 

DATES: The meeting will be held on 

Wednesday, September 20, 2023 from 

approximately 9 a.m.–6 p.m. (ET). 

ADDRESSES: The meeting will be located 

at the University of Charleston, 2300 

MacCorkle Ave. SE, Charleston, WV 

25304. To attend the meeting virtually, 

please visit www.hhs.gov/live. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Caroline Talev, MPA, Senior 

Management Analyst, at PACHA@

hhs.gov or Caroline.Talev@hhs.gov, or 

please call 202–795–7697. Additional 

information can be obtained by 

accessing the Council’s page on the 

HIV.gov site at www.hiv.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995, as amended 

by Executive Order 13009, dated June 

14, 1996 and is currently operating 

under the authority given in Executive 

Order 14048, dated September 30, 2021. 

The Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective HIV 

diagnosis, treatment, prevention, and 

quality care services. The functions of 

the Council are solely advisory in 

nature. 

The Council consists of not more than 

35 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

population health, philanthropy, 

marketing or business, as well as other 

national leaders held in high esteem 

from other sectors of society. PACHA 

selections also include persons with 

lived HIV experience and racial/ethnic 

and sexual and gender minority persons 

disproportionately affected by HIV. 

Council members are appointed by the 

Secretary. 

Dated: August 3, 2023. 

Caroline Talev, 

Senior Management Analyst, Office of 

Infectious Disease and HIV/AIDS Policy 

(OIDP), Alternate Federal Officer, PACHA, 

Office of the Assistant Secretary for Health 

(OASH), U.S. Department of Health and 

Human Services (HHS). 

[FR Doc. 2023–18267 Filed 8–23–23; 8:45 am] 

BILLING CODE 4150–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice; Solicitation of 

nominations for appointment to 

Presidential Advisory Council on HIV/ 

AIDS (PACHA). 

SUMMARY: The Office of the Assistant 

Secretary for Health (OASH) is seeking 

nominations for membership on the 

Presidential Advisory Council on HIV/ 

AIDS (referred to as PACHA and/or the 

Council). The PACHA is a federal 

advisory committee within the U. S. 

Department of Health and Human 

Services (HHS). Management support 

for the activities of this Council is the 

responsibility of the OASH. The 

qualified individuals will be nominated 

to the Secretary of Health and Human 

Services for consideration for 

appointment as members of the PACHA. 

Members of the Council, including the 

Chair, are appointed by the Secretary. 

Members are invited to serve for 

overlapping terms of up to four-year; 

terms of more than two years are 

contingent upon the authorized 

continuation of the Council. The 

Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs, policies, and 

research to promote effective treatment, 

prevention and cure of HIV and AIDS, 

including considering common comorbidities, as needed to promote 

effective HIV diagnosis, treatment, 

prevention, and quality care services. 

The functions of the Council are solely 

advisory in nature. 

DATES: Nominations for membership on 

the PACHA must be received no later 

than 8:00 p.m. (ET) Friday, January 5, 

2024. Packages received after this time 

will not be considered for the current 

membership cycle. 


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